INSYS Therapeutics Confirms Outcome of FDA Advisory Committee Meeting on Buprenorphine Sublingual Spray

INSYS Therapeutics, Inc. (NASDAQ:INSY), a leader in the development, manufacture and commercialization of pharmaceutical cannabinoids and spray technology, confirmed today that an expert panel convened by the U.S. Food and Drug Administration (FDA) voted not to recommend approval of the company’s New Drug Application (NDA) for a buprenorphine sublingual spray as a treatment for moderate-to-severe acute pain.

"We appreciate the panelists’ perspective and guidance," said Steve Sherman, senior vice president of regulatory affairs for INSYS Therapeutics. "Believing that our sublingual delivery technology could contribute significantly to bring value to patients, we will continue to work with the FDA in the coming months to discuss the path forward for our buprenorphine product candidate and to build on the current body of evidence for its efficacy and safety."

About INSYS

INSYS Therapeutics is a specialty pharmaceutical company that develops and commercializes innovative drugs and novel drug delivery systems of therapeutic molecules that improve patients’ quality of life. Using proprietary spray technology and capabilities to develop pharmaceutical cannabinoids, INSYS is developing a pipeline of products intended to address unmet medical needs and the clinical shortcomings of existing commercial products. INSYS is committed to developing medications for potentially treating addiction to opioids, opioid overdose, epilepsy, and other disease areas with a significant unmet need.

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